Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-02 @ 6:05 AM
Study NCT ID:
NCT05601193
Status:
UNKNOWN
Last Update Posted:
2022-11-01
First Post:
2022-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ovarian PRP Injection in Women With POR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 390}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-27', 'studyFirstSubmitDate': '2022-10-27', 'studyFirstSubmitQcDate': '2022-10-27', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Functional experiments of follicular fluid and granulosa cells before and after PRP injection', 'timeFrame': '1 year', 'description': 'Changes of hormone/ RNA/ protein / growth factor expression in follicular fluid and granulosa cells before and after PRP injection'}], 'primaryOutcomes': [{'measure': 'number of oocytes retrieval', 'timeFrame': '2 years', 'description': 'The number of oocytes retrieval under the same ovarian stimulation protocol before and after PRP injection'}], 'secondaryOutcomes': [{'measure': 'Ovarian function in DOR patients before and after PRP injection.', 'timeFrame': '2 years', 'description': 'Anti-müllerian Hormone (AMH) serum level, Follicle Stimulating Hormone (FSH) serum level, Estradiol (E2) serum level level on menstrual day 2/3'}, {'measure': 'Outcomes of IVF in DOR patients before and after PRP injection under the same ovarian stimulation protocol.', 'timeFrame': '3 years', 'description': 'The number of oocyte retrieval, fertilization rate , blastocyst formation rate, implantation rate, incidence of clinical pregnancy rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Poor Ovarian Response; Platelet-Rich Plasma'], 'conditions': ['Poor Ovarian Response']}, 'descriptionModule': {'briefSummary': 'Patients with poor ovarian response (POR）is considered one of most challenging tasks in artificial reproductive treatment (ART). Several retrospective studies have shown that platelet-rich plasma (PRP) is one of the proposed therapeutic strategies for women with POR. However, prospective randomized controlled trials are still lacking. This study aimed to evaluate the effect on intraovarian injection of autologous PRP in poor ovarian reserve prospectively.', 'detailedDescription': 'It will be divided two groups of POR patients according to the treatment itself. One group was treated by intraovarian injection of autologous PRP, and the other was control. It will detect the function of ovarian reserve and IVF outcomes before and after treatment in both two groups. In addition, granulosa cells and follicular fluid before and after injection were collected for functional exploration experiments.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Women less than 43 years old and undergo IVF/ICSI; 2) AMH \\< 1.1 and the number of follicles in bilateral antrum \\< 7; 3) those who have obtained less than or equal to 3 follicles in conventional controlled ovulation cycle or whose diameter ≥ 14mm on the trigger day; or have a previous history of ovarian cyst removal; if the woman is less than 40 years old, she needs to meet the inclusion criteria 2 and 3 at the same time. If you are 40 years old or older, you can join the group if you meet the inclusion criteria 2 or 3.\n\nExclusion Criteria:\n\n* 1\\) patients with clear indications or plans to undergo pre-embryo transfer genetic diagnosis (PGD) and preimplantation genetic screening (PGS); 2) patients with recurrent abortion who had more than 2 consecutive spontaneous abortions (including biochemical pregnancy); 3) men with azoospermia who underwent microsemen extraction; 4) benign ovarian cysts (endometriosis cyst, teratoma, etc.) found by B-ultrasound; 5) women with heart, liver and kidney insufficiency. 6) one of the husband and wife has chromosome abnormality; 7) the history of malignant tumor of the woman or the hereditary family history of the husband and wife 8) uterine anatomical abnormalities (including uterine adhesion, endometrial polyps, submucous myoma, uterine mediastinum, etc.) 9) untreated hydrosalpinx 10) uncontrolled endocrine abnormalities, including thyroid dysfunction, diabetes, etc. 11) other reasons that the researchers believe are not appropriate to participate in this study, such as positive for syphilis or HIV.'}, 'identificationModule': {'nctId': 'NCT05601193', 'briefTitle': 'Ovarian PRP Injection in Women With POR', 'organization': {'class': 'OTHER', 'fullName': 'Sixth Affiliated Hospital, Sun Yat-sen University'}, 'officialTitle': 'Effect of Ovarian Injection of Autologous Platelet-Rich Plasma on the Pregnancy Outcome of IVF/ICSI in Patients With Poor Ovarian Response: A Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2022ZSLYEC-495'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRP group', 'description': 'Experimental: autologous PRP Bilateral ovaries autologous PRP injection under transvaginal ultrasound guidance. 3ml on each ovary.Once a month. two consecutive injections', 'interventionNames': ['Other: autologous platelet-rich plasma']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No intervention'}], 'interventions': [{'name': 'autologous platelet-rich plasma', 'type': 'OTHER', 'description': 'autologous PRP preparation was done by segregation of PRP following the centrifugation', 'armGroupLabels': ['PRP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoyan Liang', 'role': 'CONTACT', 'email': 'liangxy2@mail.sysu.edu.cn', 'phone': '86 020-38250752'}, {'name': 'Qian Li', 'role': 'CONTACT', 'email': 'liqian226@126.com', 'phone': '15917369026'}], 'facility': 'Reproductive Medicine Research Center, the Sixth Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xiaoyan Liang', 'role': 'CONTACT', 'email': 'liangxy2@mail.sysu.edu.cn', 'phone': '86 020-38250752'}, {'name': 'Qian Li', 'role': 'CONTACT', 'email': 'liqian226@126.com', 'phone': '15917369026'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}